BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSLEAD TRACKER

    MDR report key: 21736070 · Received April 1, 2025

    Report

    Report Number
    3003775027-2025-00092
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327149921
    PMA / PMN Number
    K241510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911. THE REPORTED CROSSLEAD TRACKER GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE CONCOMITANT BALLOON CATHETER. THE RETURNED CROSSLEAD TRACKER GUIDE WIRE WAS FOUND BENT AND FRACTURED AT THE BOUNDARY WITH THE HYPO TUBE SHAFT AT APPROXIMATELY 400MM FROM THE TIP. THE SHAFT WAS TWISTED FOR APPROXIMATELY 70MM PROXIMAL TO THE FRACTURE END. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE SURFACE OF BOTH FRACTURE ENDS HAD SMALL DIMPLES, WHICH ARE TRACES OF DUCTILE FRACTURE. MULTIPLE CIRCUMFERENTIAL CRACKS WERE OBSERVED ON THE SHAFT NEAR THE FRACTURE END, INDICATING THAT BENDING STRESS HAD CONTRIBUTED TO THE FRACTURE OF THE GUIDE WIRE. THE PROVIDED BALLOON CATHETER WAS FOUND SPLIT FOR APPROXIMATELY 7MM TOWARD THE DISTAL SIDE FROM THE GUIDE WIRE PORT. TORN INNER TUBE OF THE GUIDE WIRE LUMEN WAS EXPOSED AT THE DISTAL END OF THE SPLIT SEGMENT. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE CROSSLEAD TRACKER GUIDE WIRE MIGHT HAVE BEEN CAUGHT AT THE GUIDE WIRE PORT OF THE BALLOON CATHETER DUE TO EXCESSIVE BENDING STRESS GENERATED WITH PUSHING-PULLING MANIPULATION OF THE BALLOON CATHETER OVER THE GUIDE WIRE CAUSED BY VESSEL TORTUOSITY OR THE HEAVILY CALCIFIED LESION, SPLITTING THE PORT SEGMENT. AS THE CROSSLEAD TRACKER GUIDE WIRE WAS TRAPPED, PUSHING-PULLING STRESS AND BENDING STRESS COULD ACCUMULATE ON THE BOUNDARY WITH THE HYPO TUBE SHAFT, WHERE THE STIFFNESS OF THE SHAFT CHANGES. CONSEQUENTLY, THE GUIDE WIRE WAS FRACTURED. ALTHOUGH IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY, A POSSIBILITY COULD NOT BE RULED OUT THAT SOME WIRE FRAGMENT(S) MIGHT BE LEFT IN THE PATIENT ANATOMY IF IT WERE TO RECUR. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP. [OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR.] IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. [MALFUNCTIONS AND ADVERSE EVENTS] 1. MALFUNCTIONS ~ BREAKAGE OR BENDING OF THE GUIDE WIRE. ~ DAMAGE SUCH AS SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO TREAT MODERATELY TORTUOUS, HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY (ATA). AN ASAHI CROSSLEAD TRACKER GUIDE WIRE WAS USED TO CROSS THE LESION. WHEN THE CONCOMITANT BALLOON WAS INFLATED, THE CROSSLEAD TRACKER GUIDE WIRE BECAME TRAPPED BY THE BALLOON AND FRACTURED. AS THE WIRE FRAGMENT WAS REMOVED TOGETHER WITH THE BALLOON, NOTHING WAS LEFT IN THE PATIENT ANATOMY. THE DEVICES WERE THEN REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. THE PATIENT WAS REPORTEDLY FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933650 CROSSLEAD TRACKER PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. CLT01430S 250113A311 04547327149921

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male